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Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746447
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Brief Summary:
This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Recurrence Drug: mesalamine granules Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis
Study Start Date : May 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 3.0g OD Drug: mesalamine granules
3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Salofalk granules
  • Mesalazine

Experimental: 1.5g OD Drug: mesalamine granules
1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening;
Other Names:
  • Salofalk granules
  • Mesalazine

Active Comparator: 0.5g TID Drug: mesalamine granules
0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening
Other Names:
  • Salofalk granules
  • Mesalazine

Primary Outcome Measures :
  1. Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline. [ Time Frame: week 52 or premature withdrawal ]

Secondary Outcome Measures :
  1. Time to relapse [ Time Frame: within 52 weeks ]
  2. Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination. [ Time Frame: week 52 or premature withdrawal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent,
  • Men or women aged 18 to 75 years,
  • Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology,
  • Patient being in remission, defined (according to Rachmilewitz) as:

Clinical Activity Index (CAI) <= 4, and Endoscopic Index (EI) < 4,

  • Extent of inflammation during last acute episode was >15 cm beyond the anal margin,
  • Last acute episode ended within 3 months prior to study entry.

Exclusion Criteria:

  • Crohn's disease,
  • Prior bowel resection leading to diarrhoea,
  • Toxic megacolon,
  • Gastric or duodenal ulcer,
  • Haemorrhagic diathesis,
  • Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
  • Active colorectal cancer or a history of colorectal cancer,
  • Serious other secondary illnesses of an acute or chronic nature,
  • Asthma,
  • Severe impairment of renal (e.g., serum creatinine > 1.5 mg/dl) and/or liver functions (e.g., serum transaminase [ALT and/or AST] or alkaline phosphatase >=2x upper limit of normal [ULN]),
  • Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to baseline,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e. > 6 weeks), other than acetylsalicylic acid (<= 350 mg/day), or paracetamol,
  • Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
  • Well-founded doubt about the patient's cooperation,
  • Existing or intended pregnancy, breast-feeding,
  • Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
  • Participation in another clinical trial within the last 30 days,simultaneous participation in another clinical trial, or previous participation in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746447

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Evangelisches Krankenhaus Kalk, Medical Dept.
Cologne, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Study Director: Ralph Mueller, Dr. Dr. Falk Pharma GmbH
Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00746447    
Other Study ID Numbers: SAG-27/UCR
EudraCT No.: 2004-001218-15
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by Dr. Falk Pharma GmbH:
ulcerative colitis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Disease Attributes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents